FRAME WITH VARIED STRUT WIDTHS FOR PROSTHETIC IMPLANT
A prosthetic implant has a self-expanding frame with an inflow end, an outflow end, and a plurality of struts interconnected at junctions. At least a portion of the plurality of struts have a reduced strut width at at least one junction configured to reduce or prevent infolding of the frame during recapture into a delivery cylinder of a delivery apparatus.
This application is a continuation of International Patent Application No. PCT/US2020/062644, filed on Dec. 1, 2020, which application claims the benefit of U.S. Provisional Application No. 62/942,704, filed on Dec. 2, 2019. The entire disclosure of each of these applications is incorporated herein by reference in its entirety.
FIELDThe present disclosure pertains to prosthetic implants, such as self-expanding prosthetic heart valves and support structures, as well as associated delivery apparatuses.
BACKGROUNDProsthetic cardiac valves have been used for many years to treat cardiac valvular disorders. The native heart valves (such as the aortic, pulmonary and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital, inflammatory or infectious conditions. Such damage to the valves can result in serious cardiovascular compromise or death. For many years the definitive treatment for such disorders was the surgical repair or replacement of the valve during open heart surgery, but such surgeries are prone to many complications. More recently a transvascular technique has been developed for introducing and implanting a prosthetic heart valve using a flexible catheter in a manner that is less invasive than open heart surgery.
In this technique, a prosthetic valve is mounted in a crimped state on the end portion of a flexible catheter and advanced through a blood vessel of the patient until the prosthetic valve reaches the implantation site. The prosthetic valve at the catheter tip is then expanded to its functional size at the site of the defective native valve such as by inflating a balloon on which the prosthetic valve is mounted. Alternatively, the prosthetic valve can have a resilient, self-expanding stent or frame that expands the prosthetic valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter.
Balloon-expandable prosthetic valves typically are preferred for replacing calcified native valves because the catheter balloon can apply sufficient expanding force to anchor the frame of the prosthetic valve to the surrounding calcified tissue. On the other hand, self-expanding prosthetic valves sometimes are preferred for replacing a defective, non-stenotic (non-calcified) native valve, although they also can be used to replace stenotic valves.
During implantation of a self-expanding implant such as a prosthetic valve or valve support stent, the surgeon may partially advance the implant from the delivery cylinder or sheath in which it is contained in order to assess the positioning of the implant before fully deploying it. If positional adjustment is needed, the surgeon may partially or fully retract the prosthetic implant back into the delivery sheath, a process known as “recapturing” the prosthetic implant. During implant recapture, the distal end portion of the delivery sheath can urge or guide the prosthetic implant back into the compressed state as the prosthetic implant is withdrawn back into the delivery sheath. Partial deployment and implant recapture may be performed multiple times to achieve the desired positioning before the prosthetic implant is fully deployed. However, certain self-expanding prosthetic implants, such as relatively large diameter prosthetic heart valves and support stents, can be prone to infolding in which one or more struts bend, deform, or buckle radially inwardly during recapture. Such infolding can result in a fold, crease, or pocket in the exterior of the frame, necessitating replacement of the prosthetic implant and/or balloon valvuloplasty to fully expand the prosthetic implant after deployment. Accordingly, there exists a need for improvements to frames for self-expanding prosthetic implants such as prosthetic heart valves and support stents.
SUMMARYCertain embodiments of the disclosure pertain to self-expanding frames for prosthetic implants with varying strut widths, thicknesses, junction widths, and other parameters configured to reduce or prevent infolding of the frames during recapture into a delivery cylinder of a delivery apparatus. In a representative embodiment, a prosthetic implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, and wherein at least a portion of the plurality of struts have a reduced strut width at at least one junction.
In any or all of the disclosed embodiments, the struts of the at least a portion of the plurality of struts have a reduced strut width at both junctions.
In any or all of the disclosed embodiments, the struts of the at least a portion of the plurality of struts have a reduced strut width at their inflow junctions.
In any or all of the disclosed embodiments, the struts of the at least a portion of the plurality of struts have a reduced strut width at their outflow junctions.
In any or all of the disclosed embodiments, struts of at least the second row of struts comprise a reduced strut width at their outflow junctions.
In any or all of the disclosed embodiments, the struts of at least the second row of struts comprise a reduced strut width at their inflow junctions.
In any or all of the disclosed embodiments, the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame.
In any or all of the disclosed embodiments, struts of at least the first row of struts comprise a reduced strut width at their inflow junctions.
In any or all of the disclosed embodiments, struts of at least the first row of struts comprise a reduced strut width at their outflow junctions.
In any or all of the disclosed embodiments, the struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions, wherein the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width.
In any or all of the disclosed embodiments, the third strut width is greater than the first strut width and greater than the second strut width.
In any or all of the disclosed embodiments, the first strut width and the second strut width are substantially equal.
In any or all of the disclosed embodiments, a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
In any or all of the disclosed embodiments, a ratio of the second strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
In any or all of the disclosed embodiments, a thickness of the struts is greater than the third strut width.
In any or all of the disclosed embodiments, a ratio of the third strut width to the strut thickness is greater than or equal to 0.65, or from 0.65 to 0.85.
In any or all of the disclosed embodiments, the junctions comprise a junction width, and the junction width is greater than the third strut width.
In any or all of the disclosed embodiments, a ratio of the third strut width to the junction width is 0.3 to 0.5.
In any or all of the disclosed embodiments, the struts comprise a strut thickness, and the junction width is greater than the strut thickness.
In any or all of the disclosed embodiments, a ratio of the junction width to the strut thickness is less than or equal to 2.1, or from 1.5 to 2.1.
In any or all of the disclosed embodiments, when 80% of an overall length of the prosthetic implant is deployed from a delivery cylinder of a delivery apparatus, a ratio of a diameter of the inflow end of the prosthetic implant to an inner diameter of the delivery cylinder is less than or equal to 6.0, or 5.0 to 6.0.
In any or all of the disclosed embodiments, the inflow end portions of the struts of the second row of struts comprise the first strut width, the outflow end portions of the struts of the second row of struts comprise the second strut width, and the intermediate portions of the struts of the second row of struts comprise the third strut width.
In any or all of the disclosed embodiments, each junction comprises a curved inflow surface, the curved inflow surface defining a radius, and a ratio of the second strut width of the outflow ends of the struts to the radius of the curved inflow surface is 4.0 to 7.5.
In any or all of the disclosed embodiments, all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
In any or all of the disclosed embodiments, all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
In any or all of the disclosed embodiments, the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
In any or all of the disclosed embodiments, the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve, and configured to receive a prosthetic heart valve.
In another representative embodiment, a method comprises advancing the prosthetic implant of any embodiment described herein from a delivery cylinder of a delivery apparatus in which the prosthetic implant is retained in a radially compressed state such that the inflow end of the prosthetic implant at least partially expands, and retracting the prosthetic implant back into the delivery cylinder such that the prosthetic implant returns to the radially compressed state.
In another representative embodiment, a prosthetic implant delivery apparatus comprises a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter, and a self-expanding prosthetic implant according to any of the embodiments described herein retained in a radially compressed state in the delivery cylinder.
In any or all of the disclosed embodiments, the prosthetic implant comprises a specified design diameter of at least 29 mm, and when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
In another representative embodiment, a prosthetic implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, wherein the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame. The struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions. The inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width and greater than the second strut width.
In another representative embodiment, a prosthetic implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions. The struts comprise inflow end portions coupled to respective junctions, outflow end portions coupled to respective junctions, and intermediate portions between the inflow end portions and the outflow end portions. A strut width of the intermediate portions of the struts is different from a strut width of the inflow end portions of the struts and different from a strut width of the outflow end portions of the struts. The struts comprise a strut thickness. A ratio of the strut width of the intermediate portions of the struts to the strut thickness is greater than or equal to 0.65, or 0.65 to 0.85.
In another representative embodiment, a prosthetic implant comprises a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, the junctions comprising a junction width. The struts comprise inflow end portions coupled to respective junctions, outflow end portions coupled to respective junctions, and intermediate portions between the inflow end portions and the outflow end portions. The inflow end portions of the struts comprise a first strut width, the outflow end portions of the struts comprise a second strut width, and the intermediate portions of the struts comprise a third strut width that is greater than the first strut width and greater than the second strut width. The junction width is greater than the third strut width of the intermediate portions of the struts.
In another representative embodiment, a prosthetic implant delivery apparatus comprises a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter. A self-expanding prosthetic implant retained in a radially compressed state in the delivery cylinder, the prosthetic implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions. The prosthetic implant has a specified design diameter of at least 29 mm. When the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
Described herein are embodiments of self-expanding frames for prosthetic implants with varying strut widths, thicknesses, junction widths, and/or other parameters configured to reduce or prevent infolding of the frames during recapture into a delivery cylinder/sheath of a delivery apparatus. For example, in certain embodiments, struts of the frames described herein can comprise strut widths at or near junctions between adjacent struts that are less than strut widths near the centers of the struts. In certain embodiments, a ratio of the strut width at or near the junctions to the strut width at the mid-portion of the struts within particular ranges can reduce the incidence of infolding during recapture of the frame. In certain embodiments, the struts can have a reduced strut width at their inflow junctions, at their outflow junctions, or both. In certain embodiments, the struts of the row or rows of struts at the inflow end of the frame can comprise varying strut widths as described herein. In certain embodiments, varying the strut widths as described herein can maintain a ratio of the inflow diameter of a partially deployed frame to the inner diameter of a delivery cylinder within a specified range in order to reduce infolding. For example, certain frame embodiments described herein can allow 80% or more of the overall length of the frame to be unsheathed from a delivery cylinder and then recaptured into the delivery cylinder without infolding. In certain examples, this can reduce the risk that the implant may become damaged and require replacement mid-procedure, thereby reducing procedure time and improving patient outcomes.
First Representative EmbodimentReferring first to
The illustrated prosthetic valve 10 is adapted to be deployed in the native aortic annulus, although it also can be used to replace the other native valves of the heart. Moreover, the prosthetic valve 10 can be adapted to replace other valves within the body, such venous valves.
The stent 12 has an inflow end 26 and an outflow end 27. The mesh structure formed by struts 16 comprises a generally cylindrical “upper” or outflow end portion 20, an outwardly bowed or distended intermediate section 22, and an inwardly bowed “lower” or inflow end portion 24. The intermediate section 22 desirably is sized and shaped to extend into the Valsalva sinuses in the root of the aorta to assist in anchoring the prosthetic valve in place once implanted. As shown, the mesh structure desirably has a curved shape along its entire length that gradually increases in diameter from the outflow end portion 20 to the intermediate section 22, then gradually decreases in diameter from the intermediate section 22 to a location on the inflow end portion 24, and then gradually increases in diameter to form a flared portion terminating at the inflow end 26.
When the prosthetic valve is in its expanded state, the intermediate section 22 has a diameter D1, the inflow end portion 24 has a minimum diameter D2, the inflow end 26 has a diameter D3, and the outflow end portion 20 has a diameter D4, where D2 is less than D1 and D3, and D4 is less than D2. In addition, D1 and D3 desirably are greater than the diameter of the native annulus in which the prosthetic valve is to be implanted. In this manner, the overall shape of the stent 12 assists in retaining the prosthetic valve at the implantation site. More specifically, and referring to
Known prosthetic valves having a self-expanding frame typically have additional anchoring devices or frame portions that extend into and become fixed to non-diseased areas of the vasculature. Because the shape of the stent 12 assists in retaining the prosthetic valve, additional anchoring devices are not required and the overall length L of the stent can be minimized to prevent the stent upper portion 20 from extending into the non-diseased area of the aorta, or to at least minimize the extent to which the upper portion 20 extends into the non-diseased area of the aorta. Avoiding the non-diseased area of the patient's vasculature helps avoid complications if future intervention is required. For example, the prosthetic valve can be more easily removed from the patient because the stent is primarily anchored to the diseased part of the native valve. Furthermore, in certain embodiments a shorter prosthetic valve can be more easily navigated around the aortic arch.
In particular embodiments, for a prosthetic valve intended for use in a 22-mm to 24-mm annulus, the diameter D1 is about 28 mm to about 32 mm, with 30 mm being a specific example; the diameter D2 is about 24 mm to about 28 mm, with 26 mm being a specific example; the diameter D3 is about 28 mm to about 32 mm, with 30 mm being a specific example; and the diameter D4 is about 24 mm to about 28 mm, with 26 mm being a specific example. The length L in particular embodiments is about 20 mm to about 24 mm, with 22 mm being a specific example.
Referring to
As best shown in
Referring to
The prosthetic valve 10 can be implanted in a retrograde approach where the prosthetic valve, mounted in a crimped state at the distal end of a delivery apparatus, is introduced into the body via the femoral artery and advanced through the aortic arch to the heart, as further described in U.S. Patent Publication No. 2008/0065011, which is incorporated herein by reference.
As best shown in
As best shown in
The width of the links 160 can be varied to vary the flexibility of the distal segment along its length. For example, the links within the distal end portion of the slotted tube can be relatively narrower to increase the flexibility of the shaft at that location while the links within the proximal end portion of the slotted tube can be relatively wider so that the shaft is relatively less flexible at that location.
Referring to
As best shown in
The torque shaft 110 desirably is configured to be rotatable relative to the delivery sheath 106 to effect incremental and controlled advancement of the prosthetic valve 10 from the delivery sheath 106. To such ends, and according to one embodiment, the delivery apparatus 100 can include a sheath retaining ring in the form of a threaded nut 150 mounted on the external threads of the screw 112. As best shown in
As best shown in
As noted above, the delivery apparatus 100 can include a valve-retaining mechanism 114 (
The proximal end of the outer fork 130 is connected to the distal segment 126 of the outer shaft 104 and the distal end of the outer fork is releasably connected to the stent 12. In the illustrated embodiment, the outer fork 130 and the distal segment 126 can be integrally formed as a single component (e.g., the outer fork and the distal segment can be laser cut or otherwise machined from a single piece of metal tubing), although these components can be separately formed and subsequently connected to each other. The inner fork 132 can be mounted on the nose catheter shaft 120 (as best shown in
As best shown in
Each prong of the outer fork cooperates with a corresponding prong of the inner fork to form a releasable connection with a retaining arm 30 of the stent. In the illustrated embodiment, for example, the distal end portion of each prong 134 is formed with an opening 140. When the prosthetic valve is secured to the delivery apparatus (as best shown in
Techniques for compressing and loading the prosthetic valve 10 into the sheath 106 are described below. Once the prosthetic valve 10 is loaded in the delivery sheath 106, the delivery apparatus 100 can be inserted into the patient's body for delivery of the prosthetic valve. In one approach, the prosthetic valve can be delivered in a retrograde procedure where delivery apparatus is inserted into a femoral artery and advanced through the patient's vasculature to the heart. Prior to insertion of the delivery apparatus, an introducer sheath can be inserted into the femoral artery followed by a guide wire, which is advanced through the patient's vasculature through the aorta and into the left ventricle. The delivery apparatus 100 can then be inserted through the introducer sheath and advanced over the guide wire until the distal end portion of the delivery apparatus containing the prosthetic valve 10 is advanced to a location adjacent to or within the native aortic valve.
Thereafter, the prosthetic valve 10 can be deployed from the delivery apparatus 100 by rotating the torque shaft 110 relative to the outer shaft 104. As described below, the proximal end of the torque shaft 110 can be operatively connected to a manually rotatable handle portion or a motorized mechanism that allows the surgeon to effect rotation of the torque shaft 110 relative to the outer shaft 104. Rotation of the torque shaft 110 and the screw 112 causes the nut 150 and the sheath 106 to move in the proximal direction toward the outer shaft (
In known delivery devices, the surgeon must apply push-pull forces to the shaft and/or the sheath to unsheathe the prosthetic valve. It is therefore difficult to transmit forces to the distal end of the device without distorting the shaft (e.g., compressing or stretching the shaft axially), which in turn causes uncontrolled movement of the prosthetic valve during the unsheathing process. To mitigate this effect, the shaft and/or sheath can be made more rigid, which is undesirable because the device becomes harder to steer through the vasculature. In contrast, the manner of unsheathing the prosthetic valve described above eliminates the application of push-pull forces on the shaft, as required in known devices, so that relatively high and accurate forces can be applied to the distal end of the shaft without compromising the flexibility of the device. In certain embodiments, as much as 20 lbs. of force can be transmitted to the end of the torque shaft without adversely affecting the unsheathing process. In contrast, prior art devices utilizing push-pull mechanisms typically cannot exceed about 5 lbs. of force during the unsheathing process.
After the prosthetic valve 10 is advanced from the delivery sheath and expands to its functional size (the expanded prosthetic valve 10 secured to the delivery apparatus is depicted in FIG. 42 of U.S. Pat. No. 9,867,700, which is incorporated herein by reference), the prosthetic valve remains connected to the delivery apparatus via the retaining mechanism 114. Consequently, after the prosthetic valve is advanced from the delivery sheath, the surgeon can reposition the prosthetic valve relative to the desired implantation position in the native valve such as by moving the delivery apparatus in the proximal and distal directions or side to side, or rotating the delivery apparatus, which causes corresponding movement of the prosthetic valve. The retaining mechanism 114 desirably provides a connection between the prosthetic valve and the delivery apparatus that is secure and rigid enough to retain the position of the prosthetic valve relative to the delivery apparatus against the flow of the blood as the position of the prosthetic valve is adjusted relative to the desired implantation position in the native valve. Once the surgeon positions the prosthetic valve at the desired implantation position in the native valve, the connection between the prosthetic valve and the delivery apparatus can be released by retracting the innermost shaft 120 in the proximal direction relative to the outer shaft 104, which is effective to retract the inner fork 132 to withdraw its prongs 136 from the openings 32 in the retaining arms 30 of the prosthetic valve (
The delivery apparatus 100 has at its distal end a semi-rigid segment comprised of relatively rigid components used to transform rotation of the torque shaft into axial movement of the sheath. In particular, this semi-rigid segment in the illustrated embodiment is comprised of the prosthetic valve and the screw 112. An advantage of the delivery apparatus 100 is that the overall length of the semi-rigid segment is minimized because the nut 150 is used rather than internal threads on the outer shaft to affect translation of the sheath. The reduced length of the semi-rigid segment increases the overall flexibility along the distal end portion of the delivery catheter. Moreover, the length and location of the semi-rigid segment remains constant because the torque shaft does not translate axially relative to the outer shaft. As such, the curved shape of the delivery catheter can be maintained during valve deployment, which improves the stability of the deployment. A further benefit of the delivery apparatus 100 is that the ring 128 prevents the transfer of axial loads (compression and tension) to the section of the torque shaft 110 that is distal to the ring.
In an alternative embodiment, the delivery apparatus can be adapted to deliver a balloon-expandable prosthetic valve. As described above, the valve retaining mechanism 114 can be used to secure the prosthetic valve to the end of the delivery apparatus. Since the stent of the prosthetic valve is not self-expanding, the sheath 106 can be optional. The retaining mechanism 114 enhances the pushability of the delivery apparatus and prosthetic valve assembly through an introducer sheath.
The proximal end portion of the torque shaft 110 can have a driven nut 222 (
The drive cylinder 224 is operatively connected to an electric motor 226 through gears 228 and 230. The handle can also house a battery compartment 232 that contains batteries for powering the motor 226. Rotation of the motor in one direction causes the torque shaft 110 to rotate, which in turn causes the sheath 106 to retract and uncover a prosthetic valve at the distal end of the catheter assembly. Rotation of the motor in the opposite direction causes the torque shaft to rotate in an opposite direction, which causes the sheath to move back over the prosthetic valve. An operator button 234 on the handle allows a user to activate the motor, which can be rotated in either direction to un-sheath a prosthetic valve or retrieve an expanded or partially expanded prosthetic valve.
As described above, the distal end portion of the nose catheter shaft 120 can be secured to an inner fork 132 that is moved relative to an outer fork 130 to release a prosthetic valve secured to the end of the delivery apparatus. Movement of the shaft 120 relative to the main shaft 104 (which secures the outer fork 130) can be effected by a proximal end portion 240 of the handle that is slidable relative to the main housing 244. The end portion 240 is operatively connected to the shaft 120 such that movement of the end portion 240 is effective to translate the shaft 120 axially relative to the main shaft 104 (causing a prosthetic valve to be released from the inner and outer forks). The end portion 240 can have flexible side panels 242 on opposite sides of the handle that are normally biased outwardly in a locked position to retain the end portion relative to the main housing 244. During deployment of the prosthetic valve, the user can depress the side panels 242, which disengage from corresponding features in the housing and allow the end portion 240 to be pulled proximally relative to the main housing, which causes corresponding axial movement of the shaft 120 relative to the main shaft. Proximal movement of the shaft 120 causes the prongs 136 of the inner fork 132 to disengage from the apertures 32 in the stent 12, which in turn allows the retaining arms 30 of the stent to deflect radially outwardly from the openings 140 in the prongs 134 of the outer fork 130, thereby releasing the prosthetic valve.
Alternatively, the power source for rotating the torque shaft 110 can be a hydraulic power source (e.g., hydraulic pump) or pneumatic (air-operated) power source that is configured to rotate the torque shaft. In another embodiment, the handle can have a manually movable lever or wheel that is operable to rotate the torque shaft 110.
In another embodiment, a power source (e.g., an electric, hydraulic, or pneumatic power source) can be operatively connected to a shaft, which is turn is connected to a prosthetic valve 10. The power source is configured to reciprocate the shaft longitudinally in the distal direction relative to a valve sheath in a precise and controlled manner in order to advance the prosthetic valve from the sheath. Alternatively, the power source can be operatively connected to the sheath in order to reciprocate the sheath longitudinally in the proximal direction relative to the prosthetic valve to deploy the prosthetic valve from the sheath.
During deployment of self-expanding prosthetic heart valves such as the prosthetic valve 10, the prosthetic valve may be partially deployed or unsheathed from the delivery cylinder while the surgeon assesses placement of the prosthetic valve. If repositioning the prosthetic valve is desirable, the prosthetic valve may be partially or fully withdrawn back into the delivery cylinder or “recaptured” in order to reposition the prosthetic valve in the native annulus. Depending upon factors including the diameter of the prosthetic valve, the diameter of the delivery cylinder, the proportion of the overall length of the prosthetic valve that is outside the delivery cylinder before recapture is attempted, the number of times that recapture is attempted, etc., the frame of the prosthetic heart valve may fail to uniformly recollapse to a substantially cylindrical shape when recaptured.
For example,
As the frame is withdrawn back into the delivery cylinder or “re-sheathed,” the inflow end desirably should maintain a circular or substantially circular profile with a constant or substantially constant diameter as measured at each apex 408 around the circumference of the inflow end. However, in certain instances, as the frame is withdrawn back into the delivery cylinder 402, one or more struts may bend, deform, buckle, or fold radially inward toward the longitudinal axis of the frame. This phenomenon is illustrated in
The frame can comprise a generally cylindrical “upper” or outflow end portion 512, an outwardly bowed or distended intermediate or belly portion 514, and an inwardly bowed “lower,” waist, or inflow end portion 516, similar to the frame of
When the frame is in its expanded state, the intermediate portion 514 can have a diameter D1, the waist of the inflow end portion 516 can have a minimum diameter D2, the inflow end 502 can have a diameter D3, and the outflow end portion 512 can have a diameter D4, where D2 is less than D1 and D3, and D4 is less than D2. As with the embodiments described above, D1 and D3 can be greater than the diameter of the native annulus in which the prosthetic valve is to be implanted such that the frame assists in retaining the prosthetic valve at the implantation site. In certain embodiments, this configuration can also reduce or prevent paravalvular leakage.
The struts 506 can be made of a shape memory material, such as Nitinol or other nickel titanium alloys, that allow the prosthetic valve to be compressed to a reduced diameter for delivery in a delivery apparatus (such as described above) and then causes the prosthetic valve to expand to its functional size inside the patient's body when deployed from the delivery apparatus. In other embodiments, the frame can also comprise ductile materials such as nickel-chromium alloys or stainless steel, and can be configured for use with balloon-expandable valves.
For example, the struts can comprise a thickness or width dimension measured generally in the plane of the curved exterior surface of the frame, referred to herein as the “strut width” W. Referring again to
Referring again to
Returning to
Referring to
In certain embodiments, the third strut width W3 can be larger than the strut widths W1 and W2. In certain embodiments, the strut widths W1 and W2 can be the same or different, depending upon the particular characteristics desired. In certain embodiments, the strut widths W1 and W2 can be equal or substantially equal. As used herein, the strut widths W1 and W2 are substantially equal if their values differ by 10% or less. In certain embodiments, reducing the strut width at the junctions can advantageously reduce the radial force required to crimp the valve for delivery, as further described below.
In certain embodiments, the struts 506 of each of the strut rows I-V can be configured similarly to the representative strut member 506A. In certain embodiments, the strut width of the various portions of the struts can vary between rows. For example, in certain embodiments the struts of row I or rows I and II at the inflow end portion of the frame can comprise the varying strut width configuration shown in
For example,
Any two rows of struts coupled together at junctions such as the junctions 530 can have any of the varying or constant strut width configurations described herein. For example, in certain embodiments at least a portion of the struts of the frame can comprise a reduced strut width (e.g., W1 or W2) at at least one of their respective junctions, such as at their inflow junctions (e.g., junction 530B in
In certain embodiments, a length L of the strut members 506 can be from 4 mm to 6 mm. In certain embodiments, the length L of the strut members 506 can vary based upon the specified design diameter of the frame. For example, in certain examples a frame configured as described herein having a specified design diameter of 26 mm can have a strut length L of 4.33 mm. A frame having a specified diameter of 29 mm can have a strut length L of 4.79, and a frame having a specified design diameter of 32 mm can have a length L of 5.3 mm.
Returning to
The inventors have discovered that self-expandable frames for prosthetic heart valves including one or more of the parameters described herein individually and/or in various combinations can provide surprisingly superior performance, particularly when it comes to recapturing the prosthetic valve without infolding. The parameters and frame embodiments described herein can also provide improved performance with regard to radial force required to crimp the valve for delivery, and the “chronic” outward radial force applied by the frame to the surrounding anatomy once deployed at the treatment site.
For example, in certain embodiments a ratio of the strut widths W1 and/or W2 to the strut width W3 can be 0.7 to 0.95, 0.75 to 0.95, 0.8 to 0.95, or less or equal than 0.90. In particular embodiments, the strut widths W1 and W2 can be 0.29 mm to 0.32 mm, and the strut width W3 can be 0.33 mm to 0.37 mm. Reducing the strut width near the junctions 530 can reduce the radial force required to crimp the valve for delivery, while reducing the tendency of the frame to infold during recapture.
In certain embodiments, a ratio of the strut width W3 to the strut thickness T can be 0.5 to 0.9, 0.6 to 0.85, 0.65 to 0.8, or greater than or equal to 0.65. In particular embodiments, the strut width W3 can be 0.33 mm to 0.37 mm, and the strut thickness T can be 0.47 mm to 0.50 mm. A ratio of the strut width W3 to the strut thickness T within the ranges given above can reduce the tendency of the frame to infold during recapture.
In certain embodiments, a ratio of the junction width B of the junctions 530 to the strut thickness T can be 1.4 to 3.2, such as 1.5 to 2.5, 1.5 to 2.1, or 1.5 to 2.0. In certain embodiments, the ratio of the junction width B to the strut thickness T can be greater than or equal to 1.5, or less than or equal to 2.1. In particular embodiments, the junction width B of the junctions 530 can be 0.7 mm to 1.5 mm, such as 0.8 mm to 1.0 mm, or 0.85 to 1.0 mm. In particular embodiments, the junction width B can be 0.91 mm, and the strut thickness T can be 0.47 mm to 0.50 mm. A ratio of the junction width B of the junctions to the strut thickness T within the ranges given above can provide radial force and crush resistance values within specifications for implantation in the heart, such as at the native aortic valve. For example, in certain embodiments, frames configured as described herein applied a maximum radial force of 145 N or less, such as 121 N or less, during crimping, and applied a chronic outward force of 30 N or more after expansion to the specified design diameter. These frames also displayed a crush resistance of 5 N to 8 N. In certain embodiments, the strut thickness T can have a relatively large effect on crush resistance and a relatively less pronounced effect on radial force, while the junction width B and/or the inflow and outflow strut widths W1 and W2 can have a relatively large effect on the radial force exerted by the compressed frame.
In certain embodiments, a ratio of the strut width W3 to the junction width B can be 0.25 to 0.7, such as 0.3 to 0.6, 0.3 to 0.5, or 0.3 to 0.45. In certain embodiments, the ratio of the strut width W3 to the junction width B can be greater than or equal to 0.3 or less than or equal to 0.45. In particular embodiments, the strut width W3 can be 0.33 mm to 0.37 mm, and the junction width B can be 0.7 mm to 1.5 mm, such as 0.91 mm as noted above.
In certain embodiments, a ratio of the strut width W1 and/or W2 to the junction width B can be 0.2 to 0.5, such as 0.25 to 0.45 or 0.3 to 0.4. In certain embodiments, the ratio of the strut width W1 and/or W2 to the junction width B can be greater than or equal to 0.3 or less than or equal to 0.4. In particular embodiments, the strut width W1 and/or W2 can be 0.29 mm to 0.32 mm, and the junction width B can be 0.7 mm to 1.5 mm, such as 0.91 mm as noted above.
In certain embodiments, a ratio of the strut width W2 of the outflow ends 520 of the struts to the radius r of the curved inflow surfaces 532 of the junctions can be 4.0 to 7.5, such as 4.1 to 7.1. A ratio of the strut width W1 of the inflow ends 518 of the struts to the radius r of the curved outflow surface 534 can have similar values. In particular embodiments, the radii r of the curved surfaces 532 and/or 534 of the junctions 530 can be 0.04 mm to 0.08 mm, such as from 0.044 to 0.07 mm. Radii within these ranges can improve manufacturability and accuracy of the resulting surfaces, especially when using laser-cutting techniques where the diameter of the laser beam can be 0.04 mm. Larger junction radii can promote more even heat distribution through the metal of the frame during laser cutting, and can also reduce the formation of microcracks at the junctions from repeated crimping.
In certain embodiments, after the frame is cut from a tube, the frame can be electropolished, electrochemically polished, and/or etched in an etchant. These processes can alter the strut width, thickness, and/or junction radius parameters of the as-cut frame. Thus, in certain embodiments, the mass of the frame can be used to infer whether the strut width, strut thickness, and/or junction radius parameters are within specified ranges. For example, in certain embodiments of the frame 500 configured as described herein, the mass of the frame can vary from 800 to 1,100 mg, such as between 875 mg to 1,000 mg, or 950 mg to 990 mg. In particular embodiments, the mass of the frame 500 configured as described herein can be 975 mg.
In certain embodiments, the flared inflow end portion 516 can define an angle θ with respect to the longitudinal axis 510. In certain embodiments, configuring the inflow end portion such that the angle θ is within a specified range can reduce the tendency of the frame to infold during recapture. Keeping the angle θ within a specified range can also reduce the likelihood of the inflow end portion 516 contacting the bundle of His and interfering with electrical signaling in the heart post-implantation. In certain examples, an angle θ of less 30°, such as 25° or less, or 21° or less can provide sufficient flaring of the inflow end portion 516 to anchor the prosthetic valve in the native valve annulus, while reducing the risk of infolding during recapture and/or of contacting the His bundle. In particular embodiments, an angle θ of 21° in combination with locating the frame such that 5 mm of the inflow end portion 516 extends into the left ventricle can reduce the risk of contacting the His bundle.
Another parameter that can reduce the likelihood of infolding during recapture is the ratio of the inner diameter of the delivery cylinder to the diameter of the flared inflow end of the frame when partially deployed from the delivery cylinder. In certain embodiments, the frame can be configured to expand to a specified design diameter (also referred to as a specified diameter, a design diameter, or a deployment diameter). The particular specified design diameter of the prosthetic valve can correspond to, for example, the size and shape of the individual's anatomy into which the prosthetic valve is to be implanted. For self-expanding frames configured as described herein, the specified design diameter can be measured between the interior surfaces of the frame at the narrowest point of the inflow end portion 516. In other embodiments, the specified design diameter can be measured at the location of the smallest inner diameter of the frame anywhere along its length when the frame is expanded to its functional size. The specified design diameter DSPEC of the frame 500 is illustrated in
Typically, the specified design diameter of the prosthetic heart valve is selected to be slightly larger than the patient's native annulus (e.g., a 32 mm prosthetic valve may be selected to treat a patient with a 30 mm native annulus diameter). In certain embodiments, prosthetic heart valves with a specified design diameter of at least 29 mm or larger can be more prone to infolding during recapture after partial deployment. In certain embodiments, the ratio of the diameter of the inflow end of the partially expanded prosthetic valve to the inner diameter of the delivery cylinder can affect the tendency of the frame to infold or buckle during recapture. For example,
Table 1 below provides exemplary dimensions for a 29 mm frame and a 32 mm frame configured similarly to the frame 500 of
In certain embodiments, when 80% of the overall length Y (
In certain embodiments, any of the delivery cylinders and/or apparatuses described herein can be configured to deliver other types of self-expanding implants, such as any of the prosthetic heart valve docking stations described below, stents, etc.
In addition to reducing the likelihood of infolding, the frame embodiments described herein also meet specified values for parameters including resistance to axial force (also known as crush force or crush resistance), radial force required during initial crimping of the valve, and the radial force applied by the frame against the surrounding tissue post-implantation (also known as the “chronic outward force”).
Different embodiments of the self-expanding frames described herein can provide one or more significant advantages over existing self-expanding frames. For example, certain embodiments of the frames described herein can allow repeated partial deployment and recapture of frames having a relatively large specified design diameter without infolding or invagination. For example, self-expanding frames configured as described herein having a specified design diameter of 32 mm were successfully recaptured after deploying 80% of the frame's overall length, 90% of the frame's overall length, 95% of the frame's overall length, and 98% of the frame's overall length, all without infolding. The ability to repeatedly partially deploy and recapture a large diameter self-expanding valve can provide significant advantages when attempting to place a prosthetic valve in a relatively large anatomical structure, and can reduce the risk that a new prosthetic valve may be needed mid-procedure. The frames described herein also meet specifications for radial crimping force (e.g., 145 N or less), and chronic outward force when expanded at the treatment site (e.g., 28 N to 30 N, or more).
In a representative working example, testing and measurement of the radial force and chronic outward force of a frame 500 was conducted using a radial expansion force gauge apparatus 700 illustrated in
The tester apparatus 700 was calibrated by, for example, checking that the apparatus 700 was level, and that the apparatus was at the specified temperature. In the present example, the test was conducted at 37° C. To calibrate the temperature readout of the apparatus 700, a calibrated temperature sensor such as a thermocouple and/or a calibrated digital thermometer was inserted into the environmental chamber head of the apparatus, such as into the lumen 708, to a depth of 50.8 mm to 76.2 mm. After a specified period of time (e.g., 5 minutes), a temperature compensation value was entered such that the temperature readout of the apparatus matched the temperature sensor.
To calibrate the diameter of the iris assembly 704, a 6 mm diameter gauge pin was inserted at least 40 mm into the lumen 708 and a calibration routine was run. Next, a 40 mm diameter gauge pin was inserted at least 40 mm into the iris assembly and a calibration routine was run. To calibrate load cell(s) of the apparatus 700, a calibration yoke 710 was attached or hung from specified screws 712 on the apparatus 700 when the screws 712 were level (e.g., at a diameter of 10 mm). Weights 714 of varying mass were then attached to the yoke 710 to calibrate the load cells.
Friction of the various elements of the iris assembly 704 was then checked. In the present example, the measured friction was within ±1.5 N radial force.
During the test, a preset routine was selected for the 32 mm frame starting at a first diameter of 37 mm, and radially contracting at a rate of 0.5 mm/s to a second diameter of 6.35 mm (corresponding to the inner diameter of the delivery cylinder). The frame was inserted into the lumen 708 and allowed to acclimatize for two minutes before the test was initiated. The radial force exerted by the compressed frame was then measured, the results of which are shown in the graph of radial force versus diameter illustrated in
The varied strut widths, junction widths, junction radii, etc., described above can also be implemented on frames for other types of prosthetic implants, such as docking stations or systems configured to receive a prosthetic heart valve. One representative example of such a docking station is illustrated in
In a preferred embodiment of a docking station 802, the inflow portion has walls that are impermeable to blood, but the outflow portion walls are relatively open. In one approach, the inflow end portion 804, the mid-section 808, and a portion of the outflow end portion 806 are covered with a blood-impermeable fabric 826, which may be sewn onto the stent or otherwise attached by a method known in the art. The impermeability of the inflow portion of the stent helps to funnel blood into the docking station 802 and ultimately flow through the valve that is to be expanded and secured within the docking station 802.
From another perspective, this embodiment of a docking station is designed to seal at the proximal inflow section 828 to create a conduit for blood flow. The distal outflow section, however, is generally left open, thereby allowing the docking station 802 to be placed higher in the pulmonary artery without restricting blood flow. For example, the permeable portion 830 may extend into the branch of the pulmonary artery and not impede or not significantly impede the flow of blood past the branch. In one embodiment, blood-impermeable cloth, such as a PET cloth for example, or other material covers the proximal inflow section, but the covering does not cover any or at least a portion of the distal outflow section 806. As one non-limiting example, when the docking station 802 is placed in the pulmonary artery, which is a large vessel, the significant volume of blood flowing through the artery is funneled into the valve 822 by the cloth covering 826. The cloth 826 is fluid impermeable so that blood cannot pass through. Again, a variety of other biocompatible covering materials may be used such as, for example, foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.
In the example illustrated by
The valve seat 810 can provide a supporting surface for implanting or deploying a valve 822 in the docking station 802. The retaining portions 816 can retain the docking station 802 at the implantation position or deployment site in the circulatory system. The illustrated retaining portions have an outwardly curving flare that helps secure the docking station 802 within the artery. “Outwardly” as used herein means extending away from the central longitudinal axis of the docking station. As can be seen in
The prosthetic valve 822 may be expanded at the site of the docking station via means including balloon or mechanical expansion or by self-expansion. When the valve 822 is expanded, it nests in the valve seat of the docking station 802. In one embodiment, the banded waist is slightly elastic and exerts an elastic force against the prosthetic valve 822, to help hold the prosthetic valve in place.
As noted above, any of the struts of the docking station frame 800 can comprise the varied strut widths, junction widths, junction radii, etc., described above. For example, struts of any of the various strut rows of the frame 800 can comprise the narrower or tapering strut width adjacent the junctions, and the wider intermediate strut width at portions located between junctions according to any of the ratios described herein. The width of the junctions can also be greater than the intermediate strut width according to any of the ratios described herein. A ratio of a diameter of the inflow end of the docking station 800 to the inner diameter of a delivery cylinder from which the docking station is deployed can also be less than or equal to 6.0, as described above. Any or all of these features individually and/or in combination can reduce the tendency of the docking station frame 800 to infold during deployment and recapture. Additional details regarding the docking station 800 can be found in U.S. Publication No. 2017/0231756, which is incorporated herein by reference.
Fourth Representative EmbodimentThe frame 902 can comprise a retaining portion 904 comprising an annular outer portion or wall 906 having a toroidal end surface 908. A shape set (e.g., a programmed shape of a shape memory material) of the annular outer portion 906 can bias the wall 906 radially outward into contact with/against an interior surface of a vessel (e.g., the aorta) to retain the docking station 900 and a prosthetic valve received therein at the implantation position. The frame 902 can further comprise legs or members 910 which extend from the perimeter of the frame into the lumen for supporting a valve seat 912, which can be configured to receive a prosthetic heart valve such as any of the prosthetic heart valves described herein.
Referring to
Any of the struts of the docking station frame 900 and/or 1200 can comprise the varied strut widths, junction widths, junction radii, etc., described above. For example, struts of any of the various strut rows of the frames 900 and/or 1200 can comprise the narrower or tapering strut width adjacent the junctions, and the wider intermediate strut width at portions located between junctions according to any of the ratios described herein. The width of the junctions can also be greater than the intermediate strut width according to any of the ratios described herein. A ratio of a diameter of the inflow end of the docking station frame 900 and/or 1200 to the inner diameter of a delivery cylinder from which the docking station is deployed can also be less than or equal to 6.0, as described above. The struts and junctions can also be configured such that ratios of the various strut widths to the radii of the curved surfaces of the junctions fall within any of the ranges described herein. Any or all of these features individually and/or in combination can reduce the tendency of the docking station frames 900 and 1200 to infold during deployment and recapture.
Fifth Representative EmbodimentThe junctions 1004 can also comprise a junction width B. The junction width B can be larger than the intermediate strut width W3, as described above. A ratio of the intermediate strut width W3 to the junction width B can be any of the ratios described herein. The struts 1002 can also have a strut thickness configured according to any of the dimensions and ratios described herein. In certain embodiments, the frame 1000 can be configured such that when 80% of an overall length of the frame is deployed from a delivery cylinder, a ratio of the diameter of the flared inflow end (or outflow end) of the frame to an inner diameter of the delivery cylinder is 6.0 or less. The struts and junctions can also be configured such that ratios of the various strut widths to the radii of the curved surfaces of the junctions fall within any of the ranges described herein. In certain embodiments, these features alone and/or in various combinations can reduce the tendency of the frame 1000 to infold during loading, deployment, and/or recapture of the prosthetic valve.
Any of the frame strut configurations, junction width configurations, etc., described herein can also be implemented in combination with prosthetic devices including multiple frames, or multiple layers of frames, such as inner and outer frames. Additionally, for prosthetic implants where the outflow end is deployed from the delivery sheath first, the varying strut width concepts described herein can be implemented on the struts at least at the outflow end of the frame. Such implants can include prosthetic heart valves configured for implantation (e.g., trans-septally) in the native mitral valve. For example,
A representative embodiment of the inner frame 1302 is illustrated in
Referring to
Any or all of the struts of the inner and/or outer frames of the prosthetic heart valve 1300 can comprise any of the varying strut width concepts described herein. For example,
For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.
Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.
In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, the lower end of the valve is its inflow end and the upper end of the valve is its outflow end.
As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device toward the user, while distal motion of the device is motion of the device away from the user. The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.
ADDITIONAL DESCRIPTION OF EXAMPLE EMBODIMENTS OF INTERESTIn view of the above described implementations of subject matter this application discloses the following list of examples, wherein one feature of an example in isolation or more than one feature of said example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application:
Example 1. A prosthetic implant, comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, and wherein at least a portion of the plurality of struts have a reduced strut width at at least one junction.
Example 2. The prosthetic implant of any example herein and in particular example 1, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at both junctions.
Example 3. The prosthetic implant of any example herein and in particular example 1, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at their inflow junctions.
Example 4. The prosthetic implant of any example herein and in particular example 1, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at their outflow junctions.
Example 5. The prosthetic implant of any example herein and in particular any preceding example, wherein the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame.
Example 6. The prosthetic implant of any example herein and in particular example 5, wherein struts of at least the first row of struts comprise a reduced strut width at their inflow junctions.
Example 7. The prosthetic implant of any example herein and in particular example 5 or example 6, wherein struts of at least the first row of struts comprise a reduced strut width at their outflow junctions.
Example 8. The prosthetic implant of any example herein and in particular any of examples 5-7, wherein struts of at least the second row of struts comprise a reduced strut width at their outflow junctions.
Example 9. The prosthetic implant of any example herein and in particular any of examples 5-8, wherein the struts of at least the second row of struts comprise a reduced strut width at their inflow junctions.
Example 10. The prosthetic implant of any example herein and in particular example 5, wherein the struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions, and wherein the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width.
Example 11. The prosthetic implant of any example herein and in particular example 10, wherein the third strut width is greater than the first strut width and greater than the second strut width.
Example 12. The prosthetic implant of any example herein and in particular example 10 or example 11, wherein the first strut width and the second strut width are substantially equal.
Example 13. The prosthetic implant of any example herein and in particular any of examples 10-12, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 14. The prosthetic implant of any example herein and in particular any of examples 10-13, wherein a ratio of the second strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 15. The prosthetic implant of any example herein and in particular any of examples 10-14, wherein a thickness of the struts is greater than the third strut width.
Example 16. The prosthetic implant of any example herein and in particular example 15, wherein a ratio of the third strut width to the strut thickness is greater than or equal to 0.65, or from 0.65 to 0.85.
Example 17. The prosthetic implant of any example herein and in particular any of examples 10-16, wherein the junctions comprise a junction width, and the junction width is greater than the third strut width.
Example 18. The prosthetic implant of any example herein and in particular example 17, wherein a ratio of the third strut width to the junction width is 0.3 to 0.5.
Example 19. The prosthetic implant of any example herein and in particular example 17 or example 18, wherein the struts comprise a strut thickness, and the junction width is greater than the strut thickness.
Example 20. The prosthetic implant of any example herein and in particular example 19, wherein a ratio of the junction width to the strut thickness is less than or equal to 2.1, or from 1.5 to 2.1.
Example 21. The prosthetic implant of any example herein and in particular any preceding example, wherein when 80% of an overall length of the prosthetic implant is deployed from a delivery cylinder of a delivery apparatus, a ratio of a diameter of the inflow end of the prosthetic implant to an inner diameter of the delivery cylinder is less than or equal to 6.0, or 5.0 to 6.0.
Example 22. The prosthetic implant of any example herein and in particular any of examples 10-21, wherein the inflow end portions of the struts of the second row of struts comprise the first strut width, the outflow end portions of the struts of the second row of struts comprise the second strut width, and the intermediate portions of the struts of the second row of struts comprise the third strut width.
Example 23. The prosthetic implant of any example herein and in particular any of examples 10-22, wherein each junction comprises a curved inflow surface, the curved inflow surface defining a radius, and a ratio of the second strut width of the outflow ends of the struts to the radius of the curved inflow surface is 4.0 to 7.5.
Example 24. The prosthetic implant of any example herein and in particular any of examples 10-23, wherein all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
Example 25. The prosthetic implant of any example herein and in particular any of examples 1-24, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
Example 26. The prosthetic implant of any example herein and in particular any of examples 1-24, wherein the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve and configured to receive a prosthetic heart valve.
Example 27. A method, comprising advancing the prosthetic implant of any preceding claim from a delivery cylinder of a delivery apparatus in which the prosthetic implant is retained in a radially compressed state such that the inflow end of the prosthetic implant at least partially expands, and retracting the prosthetic implant back into the delivery cylinder such that the prosthetic implant returns to the radially compressed state.
Example 28. A prosthetic implant delivery apparatus, comprising a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter, and a self-expanding prosthetic implant according to any example herein and in particular any of examples 1-26 retained in a radially compressed state in the delivery cylinder.
Example 29. The prosthetic implant delivery apparatus of any example herein and in particular example 28, wherein the prosthetic implant comprises a specified design diameter of at least 29 mm, and when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
Example 30. A prosthetic implant, comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, wherein the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame, wherein the struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions, and wherein the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width and greater than the second strut width.
Example 31. The prosthetic implant of any example herein and in particular example 30, wherein the first strut width and the second strut width are substantially equal.
Example 32. The prosthetic implant of any example herein and in particular example 30 or example 31, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 33. The prosthetic implant of any example herein and in particular any of examples 30-32, wherein a ratio of the second strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 34. The prosthetic implant of any example herein and in particular any of examples 30-33, wherein a thickness of the struts is greater than the third strut width.
Example 35. The prosthetic implant of any example herein and in particular example 34, wherein a ratio of the third strut width to the strut thickness is greater than or equal to 0.65, or from 0.65 to 0.85.
Example 36. The prosthetic implant of any example herein and in particular any of examples 30-35, wherein the junctions comprise a junction width, and the junction width is greater than the third strut width.
Example 37. The prosthetic implant of any example herein and in particular example 36, wherein a ratio of the third strut width to the junction width is 0.3 to 0.5.
Example 38. The prosthetic implant of any example herein and in particular example 36 or example 37, wherein the struts comprise a strut thickness, and the junction width is greater than the strut thickness.
Example 39. The prosthetic implant of any example herein and in particular example 38, wherein a ratio of the junction width to the strut thickness is less than or equal to 2.1, or from 1.5 to 2.1.
Example 40. The prosthetic implant of any example herein and in particular any of examples 30-39, wherein when 80% of an overall length of the prosthetic implant is deployed from a delivery cylinder of a delivery apparatus, a ratio of a diameter of the inflow end of the prosthetic implant to an inner diameter of the delivery cylinder is less than or equal to 6.0, or 5.0 to 6.0.
Example 41. The prosthetic implant of any example herein and in particular any of examples 30-40, wherein the inflow end portions of the struts of the second row of struts comprise the first strut width, the outflow end portions of the struts of the second row of struts comprise the second strut width, and the intermediate portions of the struts of the second row of struts comprise the third strut width.
Example 42. The prosthetic implant of any example herein and in particular any of examples 30-41, wherein each junction comprises a curved inflow surface, the curved inflow surface defining a radius, and a ratio of the second strut width of the outflow ends of the struts to the radius of the curved inflow surface is 4.0 to 7.5.
Example 43. The prosthetic implant of any example herein and in particular any of examples 30-42, wherein all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
Example 44. The prosthetic implant of any example herein and in particular any of examples 30-43, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
Example 45. The prosthetic implant of any example herein and in particular any of examples 30-43, wherein the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve, and configured to receive a prosthetic heart valve.
Example 46. A method, comprising advancing the prosthetic implant of any example herein and in particular any of examples 30-45 from a delivery cylinder of a delivery apparatus in which the prosthetic implant is retained in a radially compressed state such that the inflow end of the prosthetic implant at least partially expands, and retracting the prosthetic implant back into the delivery cylinder such that the prosthetic implant returns to the radially compressed state.
Example 47. A prosthetic implant delivery apparatus, comprising a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter, and a self-expanding prosthetic implant according to any example herein and in particular any of examples 30-45 retained in a radially compressed state in the delivery cylinder.
Example 48. The prosthetic implant delivery apparatus of any example herein and in particular example 47, wherein the prosthetic implant comprises a specified design diameter of at least 29 mm, and when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
Example 49. A prosthetic implant, comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, wherein the struts comprise inflow end portions coupled to respective junctions, outflow end portions coupled to respective junctions, and intermediate portions between the inflow end portions and the outflow end portions, wherein a strut width of the intermediate portions of the struts is different from a strut width of the inflow end portions of the struts and different from a strut width of the outflow end portions of the struts, wherein the struts comprise a strut thickness, and wherein a ratio of the strut width of the intermediate portions of the struts to the strut thickness is greater than or equal to 0.65.
Example 50. The prosthetic implant of any example herein and in particular example 49, wherein the ratio of the strut width of the intermediate portions of the struts to the strut thickness is 0.65 to 0.85.
Example 51. The prosthetic implant of any example herein and in particular example 49 or example 50, wherein the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame, and the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the strut width of the intermediate portions of the struts of the first row of struts is a third strut width, the third strut width being greater than the first strut width and greater than the second strut width.
Example 52. The prosthetic implant of any example herein and in particular example 51, wherein all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
Example 53. The prosthetic implant of any example herein and in particular example 51 or example 52, wherein the first strut width and the second strut width are substantially equal.
Example 54. The prosthetic implant of any example herein and in particular any of examples 51-53, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 55. The prosthetic implant of any example herein and in particular any of examples 51-54, wherein a ratio of the second strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 56. The prosthetic implant of any example herein and in particular any of examples 51-55, wherein a thickness of the struts is greater than the third strut width.
Example 57. The prosthetic implant of any example herein and in particular any of examples 49-56, wherein the junctions comprise a junction width, and the junction width is greater than the strut width of the intermediate portions of the struts.
Example 58. The prosthetic implant of any example herein and in particular example 57, wherein a ratio of the strut width of the intermediate portions of the struts to the junction width is 0.3 to 0.5.
Example 59. The prosthetic implant of any example herein and in particular example 57 or example 58, wherein the struts comprise a strut thickness, and the junction width is greater than the strut thickness.
Example 60. The prosthetic implant of any example herein and in particular example 59, wherein a ratio of the junction width to the strut thickness is less than or equal to 2.1, or from 1.5 to 2.1.
Example 61. The prosthetic implant of any example herein and in particular any of examples 49-60, wherein when 80% of an overall length of the prosthetic implant is deployed from a delivery cylinder of a delivery apparatus, a ratio of a diameter of the inflow end of the prosthetic implant to an inner diameter of the delivery cylinder is less than 6.0, or from 5.0 to 6.0.
Example 62. The prosthetic implant of any example herein and in particular example 51, wherein the outflow end portions of the struts of the second row of struts comprise the first strut width, the outflow end portions of the struts of the second row of struts comprise the second strut width, and the intermediate portions of the struts of the second row of struts comprise the third strut width.
Example 63. The prosthetic implant of any example herein and in particular any of examples 49-62, wherein each junction comprises a curved inflow surface, the curved inflow surface defining a radius, and a ratio of the strut width of the outflow ends of the struts to the radius of the curved inflow surface is 4.0 to 7.5.
Example 64. The prosthetic implant of any example herein and in particular any of examples 49-63, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
Example 65. The prosthetic implant of any example herein and in particular any of examples 49-63, wherein the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve, and configured to receive a prosthetic heart valve.
Example 66. A method, comprising advancing the prosthetic implant of any example herein and in particular any of examples 49-65 from a delivery cylinder of a delivery apparatus in which the prosthetic implant is retained in a radially compressed state such that the inflow end of the prosthetic implant at least partially expands, and retracting the prosthetic implant back into the delivery cylinder such that the prosthetic implant returns to the radially compressed state.
Example 67. A prosthetic implant delivery apparatus, comprising a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter, and a self-expanding prosthetic implant according to any example herein and in particular any of examples 49-65 retained in a radially compressed state in the delivery cylinder.
Example 68. The prosthetic implant delivery apparatus of any example herein and in particular example 67, wherein the prosthetic implant comprises a specified design diameter of at least 29 mm, and when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
Example 69. A prosthetic implant, comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, the junctions comprising a junction width, wherein the struts comprise inflow end portions coupled to respective junctions, outflow end portions coupled to respective junctions, and intermediate portions between the inflow end portions and the outflow end portions, wherein the inflow end portions of the struts comprise a first strut width, the outflow end portions of the struts comprise a second strut width, and the intermediate portions of the struts comprise a third strut width that is greater than the first strut width and greater than the second strut width, and wherein the junction width is greater than the third strut width of the intermediate portions of the struts.
Example 70. The prosthetic implant of any example herein and in particular example 69, wherein a ratio of the third strut width to the junction width is 0.3 to 0.5.
Example 71. The prosthetic implant of any example herein and in particular example 69 or example 70, wherein the first strut width and the second strut width are substantially equal.
Example 72. The prosthetic implant of any example herein and in particular any of examples 69-71, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 73. The prosthetic implant of any example herein and in particular any of examples 69-72, wherein a ratio of the second strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 74. The prosthetic implant of any example herein and in particular any of examples 69-73, wherein a thickness of the struts is greater than the third strut width.
Example 75. The prosthetic implant of any example herein and in particular example 74, wherein a ratio of the third strut width to the strut thickness is greater than or equal to 0.65, or from 0.65 to 0.85.
Example 76. The prosthetic implant of any example herein and in particular example 74 or example 75, wherein the junction width is greater than the strut thickness.
Example 77. The prosthetic implant of any example herein and in particular example 76, wherein a ratio of the junction width to the strut thickness is less than or equal to 2.1, or from 1.5 to 2.1.
Example 78. The prosthetic implant of any example herein and in particular any of examples 69-77, wherein when 80% of an overall length of the prosthetic implant is deployed from a delivery cylinder of a delivery apparatus, a ratio of a diameter of the inflow end of the prosthetic implant to an inner diameter of the delivery cylinder is less than 6.0, or from 5.0 to 6.0.
Example 79. The prosthetic implant of any example herein and in particular any of examples 69-78, wherein the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame, and the inflow end portions of the struts of the first row of struts comprise the first strut width, the outflow end portions of the struts of the first row of struts comprise the second strut width, and intermediate portions of the struts of the first row of struts comprise the third strut width, the third strut width being greater than the first strut width and greater than the second strut width.
Example 80. The prosthetic implant of any example herein and in particular example 79, wherein the inflow end portions of the struts of the second row of struts comprise the first strut width, the outflow end portions of the struts of the second row of struts comprise the second strut width, and the intermediate portions of the struts of the second row of struts comprise the third strut width.
Example 81. The prosthetic implant of any example herein and in particular any of examples 69-80, wherein each junction comprises a curved inflow surface, the curved inflow surface defining a radius, and a ratio of the second strut width of the outflow ends of the struts to the radius of the curved inflow surface is 4.0 to 7.5.
Example 82. The prosthetic implant of any example herein and in particular any of examples 69-81, wherein all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
Example 83. The prosthetic implant of any example herein and in particular any of examples 69-82, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
Example 84. The prosthetic implant of any example herein and in particular any of examples 69-82, wherein the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve, and configured to receive a prosthetic heart valve.
Example 85. A method, comprising, advancing the prosthetic implant of any example herein and in particular any of examples 69-84 from a delivery cylinder of a delivery apparatus in which the prosthetic implant is retained in a radially compressed state such that the inflow end of the prosthetic implant at least partially expands, and retracting the prosthetic implant back into the delivery cylinder such that the prosthetic implant returns to the radially compressed state.
Example 86. A prosthetic implant delivery apparatus, comprising a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter, and a self-expanding prosthetic implant according to any example herein and in particular any of examples 69-84 retained in a radially compressed state in the delivery cylinder
Example 87. The prosthetic implant delivery apparatus of any example herein and in particular example 86, wherein the prosthetic implant comprises a specified design diameter of at least 29 mm, and when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
Example 88. A prosthetic implant delivery apparatus, comprising a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter, and a self-expanding prosthetic implant retained in a radially compressed state in the delivery cylinder, the prosthetic implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, and wherein the prosthetic implant has a specified design diameter of at least 29 mm, and wherein when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
Example 89. The prosthetic implant delivery apparatus of any example herein and in particular example 88, wherein the ratio of the diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is 5.0 to 6.0.
Example 90. The prosthetic implant delivery apparatus of any example herein and in particular example 88 or example 89, wherein at least a portion of the plurality of struts of the prosthetic implant have a reduced strut width at at least one junction.
Example 91. The prosthetic implant delivery apparatus of any example herein and in particular example 90, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at both junctions.
Example 92. The prosthetic implant delivery apparatus of any example herein and in particular example 90, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at their inflow junctions.
Example 93. The prosthetic implant of any example herein and in particular any of examples 90-92, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at their outflow junctions.
Example 94. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 88-93, wherein the struts of the prosthetic implant define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame.
Example 95. The prosthetic implant delivery apparatus of any example herein and in particular example 94, wherein struts of at least the first row of struts comprise a reduced strut width at their inflow junctions.
Example 96. The prosthetic implant of any example herein and in particular example 94 or example 95, wherein struts of at least the first row of struts comprise a reduced strut width at their outflow junctions.
Example 97. The prosthetic implant of any example herein and in particular any of examples 94-96, wherein struts of at least the second row of struts comprise a reduced strut width at their outflow junctions.
Example 98. The prosthetic implant of any example herein and in particular example 97, wherein the struts of at least the second row of struts comprise a reduced strut width at their inflow junctions.
Example 99. The prosthetic implant delivery apparatus of any example herein and in particular example 94, wherein the struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions, and wherein the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width.
Example 100. The prosthetic implant delivery apparatus of any example herein and in particular example 99, wherein the third strut width is greater than the first strut width and greater than the second strut width.
Example 101. The prosthetic implant delivery apparatus of any example herein and in particular example 99 or example 100, wherein the first strut width and the second strut width are substantially equal.
Example 102. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-106, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 103. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-102, wherein a ratio of the second strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
Example 104. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-103, wherein a thickness of the struts is greater than the third strut width.
Example 105. The prosthetic implant delivery apparatus of any example herein and in particular example 104, wherein a ratio of the third strut width to the strut thickness is greater than or equal to 0.65, or from 0.65 to 0.85.
Example 106. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-105, wherein the junctions comprise a junction width, and the junction width is greater than the third strut width.
Example 107. The prosthetic implant delivery apparatus of any example herein and in particular example 106, wherein a ratio of the third strut width to the junction width is 0.3 to 0.5.
Example 108. The prosthetic implant delivery apparatus of any example herein and in particular example 106 or example 107, wherein the struts comprise a strut thickness, and the junction width is greater than the strut thickness.
Example 109. The prosthetic implant delivery apparatus of any example herein and in particular example 108, wherein a ratio of the junction width to the strut thickness is less than or equal to 2.1, or from 1.5 to 2.1.
Example 110. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-109, wherein the inflow end portions of the struts of the second row of struts comprise the first strut width, the outflow end portions of the struts of the second row of struts comprise the second strut width, and the intermediate portions of the struts of the second row of struts comprise the third strut width.
Example 111. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-110, wherein each junction comprises a curved inflow surface, the curved inflow surface defining a radius, and a ratio of the second strut width of the outflow ends of the struts to the radius of the curved inflow surface is 4.0 to 7.5.
Example 112. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 99-111, wherein all struts of the frame comprise the first strut width, the second strut width, and the third strut width.
Example 113. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 88-112, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
Example 114. The prosthetic implant delivery apparatus of any example herein and in particular any of examples 88-113, wherein the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve, and configured to receive a prosthetic heart valve.
In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is at least as broad as the following claims. We therefore claim all that comes within the scope and spirit of these claims.
Claims
1. A prosthetic implant comprising:
- a frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, and wherein at least a portion of the plurality of struts have a reduced strut width at at least one junction.
2. The prosthetic implant of claim 1 wherein the frame is a self-expanding frame.
3. The prosthetic implant of claim 1, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at their inflow junctions.
4. The prosthetic implant of claim 1, wherein the struts of the at least a portion of the plurality of struts have a reduced strut width at their outflow junctions.
5. The prosthetic implant of claim 1, wherein the plurality of struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame.
6. The prosthetic implant of claim 5, wherein struts of at least the first row of struts comprise a reduced strut width at their inflow junctions.
7. The prosthetic implant of claim 5, wherein struts of at least the first row of struts comprise a reduced strut width at their outflow junctions.
8. The prosthetic implant of claim 5, wherein struts of at least the second row of struts comprise a reduced strut width at their inflow junctions.
9. The prosthetic implant of claim 5, wherein the struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions; and
- wherein the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width.
10. The prosthetic implant of claim 9, wherein the third strut width is greater than the first strut width and greater than the second strut width.
11. The prosthetic implant of claim 9, wherein the first strut width and the second strut width are substantially equal.
12. The prosthetic implant of claim 9, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
13. The prosthetic implant of claim 1, wherein when 80% of an overall length of the prosthetic implant is deployed from a delivery cylinder of a delivery apparatus, a ratio of a diameter of the inflow end of the prosthetic implant to an inner diameter of the delivery cylinder is less than or equal to 6.0, or 5.0 to 6.0.
14. The prosthetic implant of claim 1, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame.
15. The prosthetic implant of claim 1, wherein the prosthetic implant is a docking station configured to be implanted in an annulus of a native heart valve and configured to receive a prosthetic heart valve.
16. The prosthetic implant of claim 1 wherein the prosthetic implant is a balloon-expandable prosthetic valve adapted to be mounted in a compressed state on the balloon of a delivery catheter.
17. A prosthetic implant delivery apparatus, comprising:
- a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter; and
- a prosthetic implant comprising a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, and wherein at least a portion of the plurality of struts have a reduced strut width at at least one junction, the prosthetic implant retained in a radially compressed state in the delivery cylinder.
18. The prosthetic implant delivery apparatus of claim 17, wherein:
- the prosthetic implant comprises a specified design diameter of at least 29 mm; and
- when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
19. A prosthetic implant, comprising:
- a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions, wherein the struts define a first row of struts at the inflow end of the frame, a second row of struts at the outflow end of the frame, and at least one row of struts between the inflow end and the outflow end of the frame;
- wherein the struts comprise inflow end portions, outflow end portions, and intermediate portions between the inflow end portions and the outflow end portions; and
- wherein the inflow end portions of the struts of the first row of struts comprise a first strut width, the outflow end portions of the struts of the first row of struts comprise a second strut width, and the intermediate portions of the struts of the first row of struts comprise a third strut width that is greater than the first strut width and greater than the second strut width.
20. The prosthetic implant of claim 19, wherein the first strut width and the second strut width are substantially equal.
21. The prosthetic implant of claim 19, wherein a ratio of the first strut width to the third strut width is less than or equal to 0.95, or from 0.7 to 0.95.
22. The prosthetic implant of claim 19, wherein the prosthetic implant is a prosthetic heart valve comprising a plurality of leaflets coupled to the frame and configured to regulate a flow of blood through the frame or a docking station configured to be implanted in an annulus of a native heart valve, and configured to receive a prosthetic heart valve.
23. A prosthetic implant delivery apparatus, comprising:
- a catheter comprising a handle portion at a proximal end portion of the catheter and an elongated shaft extending from the handle portion, the catheter further comprising a delivery cylinder at a distal end portion of the shaft, the delivery cylinder comprising an inner diameter; and
- a self-expanding prosthetic implant retained in a radially compressed state in the delivery cylinder, the prosthetic implant comprising: a self-expanding frame having an inflow end, an outflow end, and a plurality of struts, the struts being interconnected at junctions; and wherein the prosthetic implant has a specified design diameter of at least 29 mm; and
- wherein when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
24. A method, comprising:
- advancing a self-expanding prosthetic implant from a delivery cylinder of a delivery apparatus in which the prosthetic implant is retained in a radially compressed state such that the inflow end of the prosthetic implant at least partially expands; and
- retracting the prosthetic implant back into the delivery cylinder such that the prosthetic implant returns to the radially compressed state;
- wherein when the prosthetic implant is partially deployed from the delivery cylinder such that at least 80% of an overall length of the prosthetic implant is unsheathed, a ratio of a diameter of the inflow end of the prosthetic implant to the inner diameter of the delivery cylinder is less than or equal to 6.0.
Type: Application
Filed: Jun 1, 2022
Publication Date: Sep 22, 2022
Inventors: Lien Huong Thi Hoang (San Juan Capistrano, CA), Venkateswaran Shanmugam (Lake Forest, CA)
Application Number: 17/805,019